Citric Acid by Ashahi Chemicals USA LLC Citric Acid

Citric Acid by

Drug Labeling and Warnings

Citric Acid by is a Otc medication manufactured, distributed, or labeled by Ashahi Chemicals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CITRIC ACID- citric acid liquid 
Ashahi Chemicals USA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Citric Acid

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Citric Acid 3.5% v/v. Purpose: Antiseptic

Purpose

Antiseptic, hand sanitizer

Use

Hand and surface treatment to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

purified water USP

Package Label - Principal Display Panel

946 mL NDC: 80866-001-01

3785 mL NDC: 80866-001-02

CITRIC ACID 
citric acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80866-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	5.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80866-001-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2020
2	NDC: 80866-001-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/15/2020	10/15/2020

Labeler - Ashahi Chemicals USA LLC (111671300)

Revised: 9/2021

Document Id: cbce22d5-530a-52e8-e053-2995a90a288e

34390-5

Set id: b1c06b29-0c55-ffd2-e053-2995a90ae780

Version: 3

Effective Time: 20210912